Discover the Triple Effect
of Semavic®

Active ingredient: semaglutide

Semavic® reduces the risk of major adverse cardiovascular events^{(1) Instruction for Medical Use of Semavic®}
Semavic® decreases triglycerides and cholesterol concentrations^{(1) Instruction for Medical Use of Semavic®}
Semavic® decreases systolic blood pressure^{(1) Instruction for Medical Use of Semavic®}

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Semavic® decreases blood glucose levels (plasma glucose and glycated haemoglobin (HbA1c)) in adult type 2 diabetes patients^{(1) Instruction for Medical Use of Semavic®}

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Semavic® suppresses appetite and reduces daily calorie intake by 18–35 %^{(1) Instruction for Medical Use of Semavic®}
Semavic® helps lose weight, mainly through fat tissue loss^{(1) Instruction for Medical Use of Semavic®}

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The active ingredient in Semavic® is semaglutide, a glucagon-like peptide-1 analogue that is produced and secreted in the human body and regulates insulin secretion

Semaglutide effects

BRAIN

Food intake ^{(7)
Bagger JI, et al. Clin Endocrinol Metab 2015}

Satiety ^{(8)
Flint A, et al. J Clin Invest 1998} ^{(9)
Blundell J, et al. Oral Presentation 23-OR at the 76th Scientific Sessions of the American Diabetes Association, 10–14 June 2016, New Orleans, Louisiana, USA.}

Neuroprotection ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

STOMACH

Stomach emptying ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013} ^{(10)
Tong J, D'Alessio D. Diabetes 2014}

LIVER

Endogenous
glucose production ^{(11)
Armstrong MJ, et al. J Hepatol 2016}

Hepatic insulin
sensitivity ^{(11)
Armstrong MJ, et al. J Hepatol 2016}

De novo lipogenesis ^{(11)
Armstrong MJ, et al. J Hepatol 2016}

Fatty liver ^{(12)
Armstrong MJ, et al. Lancet 2016}

BODY WEIGHT

Fat tissue ^{(1)
Instruction for Medical Use of Semavic®}

KIDNEYS

Risk of dysfunction ^{(13)
Semaglutide and cardiovascular outcomes in patients with type 2
diabetes}

PANCREAS

Beta cell function ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

Beta cell apoptosis ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

Insulin biosynthesis ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

Glucose-dependent
insulin secretion ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

Glucose-dependent
glucagon secretion ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

HEART

Cardiovascular risk ^{(3)
Marso SP, et al. N Engl J Med 2016}

Heart function ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

Systolic blood
pressure ^{(4)
Ryan D, Acosta A. Obesity 2015}

Inflammation ^{(5)
Hogan AE, et al. Diabetologia 2014}

BODY WEIGHT

Fat tissue ^{(1)
Instruction for Medical Use of Semavic®}

BRAIN

Food intake ^{(7)
Bagger JI, et al. Clin Endocrinol Metab 2015}

Satiety ^{(8)
Flint A, et al. J Clin Invest 1998} ^{(9)

Blundell J, et al. Oral Presentation 23-OR at the 76th Scientific Sessions of the American Diabetes Association, 10–14 June 2016, New Orleans, Louisiana, USA.}

Neuroprotection ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

PANCREAS

Beta cell function ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

Beta cell apoptosis ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

Insulin biosynthesis ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

Glucose-dependent
insulin secretion ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

Glucose-dependent
glucagon secretion ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013}

STOMACH

Stomach emptying ^{(2)
Campbell JE, DJ Drucker. Cell Metab 2013} ^{(10)
Tong J, D'Alessio D. Diabetes 2014}

KIDNEYS

Risk of dysfunction^{(13)
Semaglutide and cardiovascular outcomes in patients with type 2
diabetes}

LIVER

Endogenous
glucose production ^{(11)
Armstrong MJ, et al. J Hepatol 2016}

Hepatic insulin
sensitivity ^{(11)
Armstrong MJ, et al. J Hepatol 2016}

De novo lipogenesis ^{(11)
Armstrong MJ, et al. J Hepatol 2016}

Fatty liver ^{(12)
Armstrong MJ, et al. Lancet 2016}

HEART

Cardiovascular risk ^{(3)
Marso SP, et al. N Engl J Med 2016}

Heart function ^{(4)
Ryan D, Acosta A. Obesity 2015}

Systolic blood
pressure ^{(4)
Ryan D, Acosta A. Obesity 2015}

Inflammation ^{(5)
Hogan AE, et al. Diabetologia 2014}

Semavic® injections

1. Check the name on the pen injector label

Make sure that the pen injector contains Semavic® 0.25 mg/dose, 0.5 mg/dose, 1 mg/dose. This is especially important if you use several injectable medicinal products.

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2. Hold the pen injector in one hand and then pull the cap with the other hand to remove it.

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3. Make sure that the solution in the pen injector is a clear, colourless, or almost colourless solution

Look at the cartridge holder window of the pen injector.

Note: If the solution is opaque, coloured or with foreign impurities, don’t use the pen injector!

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4. Take a new needle and remove the protective sticker from the outer needle cap

Note: Use needles strictly as recommended by your doctor. Use a new needle for each injection to minimise the risk of injecting the wrong dose, infection, and tissue injury.

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5. Use the outer cap to insert the needle right into the cartridge holder

Tighten it so that the needle is securely attached to the pen injector.

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6. Remove the outer needle cap and keep it

You will need it after the injection to remove the needle from the pen injector safely.

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7. Gently pull off the inner needle cap and discard it

Hold the pen injector with needle up. Tap the cartridge holder gently to drive air bubbles to the top of the cartridge.

Small bubbles are acceptable.

Note: The needle becomes visible (emerges) as the inner cap is removed.

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8. Before your first injection with the new pen injector, check whether the medicinal product passes through the needle

Rotate the dose selector until the «» solution pass indicator is aligned with the dose pointer. You will hear 2 (two) clicks while turning the selector to the check indicator.

Note: If the dosage selector has skipped the required symbol, turn it in the opposite direction to adjust the position of the check symbol. If the pen is already in use, start using it from the "Setting the dose" item. Note: If the dosage selector...

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9. Hold the pen injector with its needle pointing up and press and hold the dose button

The dose selector will click and the dose window will show “0”. One or two drops of solution will appear at the needle tip.

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10. Rotate the dose selector until it shows the dose you need: 0.25 mg, 0.5 mg, or 1 mg.

The selected dose must be exactly opposite the dose indicator.

Note: If you selected the wrong dose, rotate the dose selector forward or backward to select the dose you need.

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11. To see how much of the medicinal product remains, rotate the dose selector until the dose counter stops

If the dosing window shows “1”, then at least 1 mg of the medicinal product remains in the pen injector. If the dose counter stops before “1” appears, then there is not enough medicinal product left in the pen injector to administer a full dose of 1 mg.

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12. Insert the needle under the skin in one continuous movement of the hand

Note: Use injection techniques recommended by your doctor or nurse.

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13. Make sure that the dose window is clearly visible to the person performing the injection.

Press the dose button and hold it until “0” is aligned with the dose indicator. When the button is pressed, the patient may hear or feel a slight click.

Do not touch the dose counter in the dose window lest you interrupt the injection.

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14. Hold the needle under the skin after the dose counter has returned to “0” and slowly count to 6.

Note: If you remove the needle from under the skin earlier, some of the medicinal product may leak out of the needle. In this case, an incomplete dose of the medicinal product will be injected.

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15. Carefully remove the needle from under the skin.

Note: If blood appears at the injection site, slightly press a cotton swab against the injection site. Don’t massage the injection site. After the injection is completed, a drop of the solution at the needle tip may appear. It is acceptable and doesn’t affect the actually injected dose of the medicinal product.

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16. Carefully lead the needle into the big outer needle cap all the way once the injection is completed

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17. Carefully unscrew the needle and discard it with the outer cap

Note: For disposal, follow local requirements, rules, and regulations for handling potentially contaminated materials.

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18. Put the cap on the pen injector and store your pen injector until the next use in the storage conditions indicated in the product instruction for use.

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Video instruction

FAQ

Is Semavic® indeed not an insulin?

Semavic® is not an insulin, it belongs to another class of medicines. Moreover, its mechanism of action focuses on reducing insulin resistance, that is, normalising human cells’ sensitivity to endogenous insulin. Semaglutide also improves the function of pancreatic cells. To sum it up, its activity is focused on normalising the body functions and enables you to manage type 2 diabetes or even reverse it, improve its prognosis, and substantially delay the initiation of insulin-replacement therapy

Would I need to inject Semavic® my entire life?

In type 2 diabetes, Semavic® therapy has to be long-term to reduce insulin resistance and have a beneficial effect on pancreatic cells that produce insulin. Moreover, it helps normalise systolic blood pressure and lipid profile and has many other benefits.

When semaglutide is used to lose weight, the treatment length depends on various factors: how long a person has been overweight, how much food and calories they consumed before the therapy initiation, how easily and fast they lose weight, whether or not they are physically active, how many hours of sleep they have, etc. The optimal weight loss rate is 5 % in 3 months on average. Firstly, a faster weight loss is stressful for the body; secondly, a faster weight loss triggers the “obesogenic memory” factor that induces weight regain after a successful obesity treatment. A medical panel may decide to prescribe semaglutide to help the body develop a habit of eating less to gradually lose weight. A prescribed treatment cycle is, in general, 6 months to 2 years.

What is the proper technique for inserting a needle into a pen injector?

Please remember to use a new needle for each injection to minimise the risk of the wrong dose, infection, and tissue injury.

1) Remove the protective sticker from needle’s outer side and *SCREW* it on to secure it on the pen injector and prevent it from shifting, as shown in the product instruction for use. The pen injector may break if the needle is not secured.

2) Remove the outer needle cap and keep it. You will need it after the injection to safely remove the needle from the pen injector

3) Remove the inner cap and discard it. The needle will emerge. Carefully lead the needle into the big outer needle cap all the way once the injection is completed

4) Carefully unscrew the needle and discard it with the outer cap

What should I do if I have such side effects as nausea, vomiting, or constipation at the therapy initiation?

What are the diet and lifestyle recommendations when Semavic® is prescribed?

Which is the right way to carry Semavic® during the warm periods?

Wrong temperature conditions may compromise product’s efficacy. There are several ways to carry Semavic® safely.

First, use icepacks. These are gel- or water-filled bags or plastic containers accumulating cold. Plastic icepacks are more reliable: they cannot be torn, and the liquid within can be partially thawed to prevent the product from freezing.

Now, select container:

Insulated containers are made of durable plastic or cardboard. They are insulated inside. You can place refrigerated icepacks inside, along the walls.
Cool carriers are made of thick insulating fabric. Icepacks can be placed inside it.

To carry the product for a short time (up to one and a half hours), you can use a foil lunch box, an ordinary insulated flask, an insulated beauty case, or an insulated lunch box bag.

What if there are no more needles in Semavic® pack, but some of the product still remains?

There are four 4-mm-long disposable needles in Semavic® pack; that is, a pen injector is designed for four injections of 1 mg therapeutic dose. When the dose is titrated or a therapeutic dose is below 1 mg, buy more needles in a pharmacy or a diabetic store.

Inject Semavic® only with the needles up to 8 mm long. The pen injector is to be used with disposable injection needles. Any universal needles are suitable, inculding:

Name	Manufacturer	Gauge (G)	Length (mm)
Verifine	-	29, 30, 31, 32	4, 5, 6, 8, 12
Dexfine	IME-DC, Germany	31, 32	4, 5, 6
WellFine	Korea	31, 32, 34	4, 5, 6, 8
Insupen	Artsana S.P.A.	30, 31, 32	4, 5, 6, 8
Micro Fine	Becton Dickinson	30, 31, 32	4, 5, 8, 12.7
SFM needles	-	29, 30, 31, 32	4, 5, 6, 8, 12.7
Novo-Fine	Novo Nordisk	30, 31	6, 8
Droplet	HTL-Strefa. Inc.	29	12
Penfine	Ypsomed	29, 31	6, 8, 10, 12

Is Semavic® as efficacious as Ozempic?

GEROPHARM conducted clinical studies that demonstrated Semavic® to be fully identical to Ozempic

May I share my Semavic® pen with other patients?

No! Never share your Semavic® pen with other people, even if the needle is new. You may infect other people or contract an infection.

Is it possible to lose weight with Semavic®?

The weight loss was greater with semaglutide (the active ingredient in Semavic®) than with the studied comparators (including sitagliptin and dulaglutide). The weight loss with semaglutide is mostly due to the loss of fat tissue, which is 3 times greater than the loss of muscle tissue.

Can I regain weight if I stop taking Semavic®?

To date, no such studies have been conducted, given that the product is indicated for continuous use by patients with type 2 diabetes.

Does Semavic® indeed reduces the cardiovascular risk?

Yes. A study demonstrated that in adult patients with type 2 diabetes and a heart disease diagnosis, the risk of major adverse cardiovascular events, such as stroke, heart attack, etc., is significantly (by 26 %) lower with semaglutide.

Does Semavic® lower blood sugar levels?

Semavic® helps your body produce its own insulin, prevents the release of too much glucose from the liver depots, and delays the stomach emptying.

1.Instruction for Medical Use of Semavic®

2.Campbell JE, DJ Drucker. Cell Metab 2013;17:819–37.

3.Marso SP, et al. N Engl J Med 2016;375:311–22.

4.Ryan D, Acosta A. Obesity 2015;23:1119–29.

5.Hogan AE, et al. Diabetologia 2014;57:781–4.

6.Baggio LL, Drucker DJ. J Clin Invest 2014;124:4223–6.

7.Bagger JI, et al. Clin Endocrinol Metab 2015;100:4541–52.

8.Flint A, et al. J Clin Invest 1998;101:515–20.

9.Blundell J, et al. Oral Presentation 23-OR at the 76th Scientific Sessions of the American Diabetes Association, 10–14 June 2016, New Orleans, Louisiana, USA.

10.Tong J, D'Alessio D. Diabetes 2014;63:407–9.

11.Armstrong MJ, et al. J Hepatol 2016;64:399–408.

12.Armstrong MJ, et al. Lancet 2016;387:679–90.

13.Marso SP, Bain SC, Consoli A, et al. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. N Engl J Med. 2016;375:1834-1844 (SUSTAIN 6).